| An SI Board Since July 1997 |
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ERGO |
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Ergo Science Corporation (ERGO) has shown that the administration of brain-altering drugs can shift daily hormone secretion patterns which may provide effective therapy for Type II diabetes and obesity. In humans, adult-onset or Type II diabetes is characterized by low-sensitivity of the body's tissues to insulin for moving blood sugar (glucose) into various organs including the brain, heart, and skeletal muscle. Diabetes has become one of the largest medical problems in many industrialized countries. Of an estimated 16 million diagnosed and undiagnosed diabetics, approximately 15 million people suffered from Type II diabetes last year in the U.S. alone and that number is expected to increase to 32 million by 2010. Obesity afflicts approximately 58 million Americans, or approximately 33% of the U.S. adult population, and over 45% of the entire population is overweight. Obesity is considered a primary risk factor for Type II diabetes, cardiovascular diseases, and many other "diseases of civilization" including some cancers. Moreover, approximately 30% of obese Americans have been diagnosed with Type II diabetes. On June 23 rd , ERGO hel d a press conference to di scuss data that was presented at the annual Ameri can Di abetes Associ ati on meetings. Based on the clinical utility demonstrated in Phase III trials for ERGOSET and the competitive advantage that we expect the product to build over currently marketed Type II diabetes therapies once, and if, the drug is approved, we believe the Company's products will serve an important role in the treatment of diabetes, and possibly obesity. ERGO has demonstrated in Phase III clinical trials that ERGOSET is safe, e fficaceous, and has clinical utility in the control of glucose metabolism for the treatment of Type II diabetes. The Company has completed three Phase III trials involving over 620 patients with Type II diabetes at 17 investigational sites, and announced preliminary analysis of these trials in July and December of 1996. In ERGOSET efficacy trials, the Company has observed that the drug not only improves control over glucose, a minimal requirement for approval, but it has certain advantages in the management of fat metabolism. If ERGO is able to commercialize a Type II diabetes therapy that not only improves control over glucose, but also decreases circulating cholesterol and other fats, the Company could have a significant competitive advantage over other currently marketed diabetes treatments that do not directly impact lipid (fat) metabolism and risk factors for cardiovascular disease.
ú, ERGO's approach to treating diabetes and obesity represents a new class of therapeutics. In contrast, most of the other therapeutic classes of drugs only treat the "symptoms" of the disease: Precose slows the absorption of carbohydrates, thus decreasing the spike of high blood sugar seen after eating; Glucophage stimulates the secretion of insulin, thus increasing circulating insulin; Rezulin stimulates the production of glucose transporting proteins by fat cells and skeletal muscle cells. However, circadian rhythm function has been demonstrated in numerous animal species to be the root cause of changes in metabolic, some of which are excellent models for human Type II diabetes and obesity. ERGOSET is the first antidiabetic postulated to have a direct effect on circadian rhythms and the scientists at ERGO are pioneers in the fields of chronobiology and neuroendochrinology. ERGO's approach to Type II diabetes treatment is different from the relatively limited actions on select "downstream" biochemical/physiological events that contribute to diabetes by current therapies.
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